The U.S. Food and Drug Administration has cleared Irvine (Calif.) Biomedical to market its Therapy Cool Flex Ablation Catheter as a treatment for typical atrial flutter.
The Cool Flex Ablation Catheter is inserted through a blood vessel and manually maneuvered into the heart. It finds the source of the abnormal heart rhythm and destroys small areas of heart tissue to treat the arrhythmia.
A clinical study found typical atrial flutter was corrected within 30 minutes in 98 percent of patients after undergoing cardiac catheter ablation treatment, according to the report.
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